Adzenys ER

Product NDC
70165-003
11-digit product format
701650003
Labeler code
70165
Product ID
70165-003_c3cb469d-d045-c37f-e053-2a95a90a34cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphetamine
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Neos Therapeutics Brands, LLC
Application
NDA204325
Marketing category
NDA
Marketing start
2017-09-16
Marketing end
0000-00-00
Substance
AMPHETAMINE
Active strength
1 mg/mL
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70165-003DDiscontinued by firm2026-08-07
excluded packagepackage70165-00370165-003-15DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70165-003-15DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70165-003-15DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70165-003-15DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70165-003-15DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70165-003-15DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70165-003-15DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70165-003-15DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70165-003-15DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70165-003-15DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70165-003-15DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70165-003-15DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70165-003-15DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage70165-003-15EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204325-001ADZENYS ERAMPHETAMINEEQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-15

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204325-00187094912032-06-28Drug product2017-09-21
N204325-00190177312032-06-28Drug product2017-09-21
N204325-00192657372032-06-28Drug product2017-09-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2017-09-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2017-09-1587673890dc5c…
2021-03-12 10:30 UTC2021-03N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2017-09-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2017-09-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2017-09-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2017-09-153f01610625f2…
2019-09-15 20:21 UTC2019-09N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2017-09-15b00525d2431f…
2019-07-19 19:46 UTC2019-07N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2017-09-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-153f0d92c62455…
2023-05-13 08:27 UTC2023-05N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-15053a50430f4f…
2023-01-26 05:58 UTC2023-01N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N204325-001ADZENYS EREQ 1.25MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD2017-09-15cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N204325-00187094912032-06-28Drug product2017-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204325-00190177312032-06-28Drug product2017-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204325-00192657372032-06-28Drug product2017-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204325-00187094912032-06-28Drug product2017-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204325-00190177312032-06-28Drug product2017-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204325-00192657372032-06-28Drug product2017-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N204325-00187094912032-06-28Drug product2017-09-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204325-00190177312032-06-28Drug product2017-09-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204325-00192657372032-06-28Drug product2017-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204325-00187094912032-06-28Drug product2017-09-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204325-00190177312032-06-28Drug product2017-09-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204325-00192657372032-06-28Drug product2017-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204325-00187094912032-06-28Drug product2017-09-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204325-00190177312032-06-28Drug product2017-09-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204325-00192657372032-06-28Drug product2017-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204325-00187094912032-06-28Drug product2017-09-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204325-00190177312032-06-28Drug product2017-09-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204325-00192657372032-06-28Drug product2017-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204325-00187094912032-06-28Drug product2017-09-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204325-00190177312032-06-28Drug product2017-09-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204325-00192657372032-06-28Drug product2017-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204325-00187094912032-06-28Drug product2017-09-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204325-00190177312032-06-28Drug product2017-09-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204325-00192657372032-06-28Drug product2017-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204325-00187094912032-06-28Drug product2017-09-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204325-00190177312032-06-28Drug product2017-09-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204325-00192657372032-06-28Drug product2017-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204325-00187094912032-06-28Drug product2017-09-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N204325-00190177312032-06-28Drug product2017-09-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N204325-00192657372032-06-28Drug product2017-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204325-00187094912032-06-28Drug product2017-09-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204325-00190177312032-06-28Drug product2017-09-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204325-00192657372032-06-28Drug product2017-09-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204325-00187094912032-06-28Drug product2017-09-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204325-00190177312032-06-28Drug product2017-09-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204325-00192657372032-06-28Drug product2017-09-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204325-00187094912032-06-28Drug product2017-09-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204325-00190177312032-06-28Drug product2017-09-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204325-00192657372032-06-28Drug product2017-09-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204325-00187094912032-06-28Drug product2017-09-218072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70165-003-15ML - Milliliter70165-003b8a3461b-0992-4c70-abbe-f13bbad9504412018-02-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70165-003-1570165000315450 mL in 1 BOTTLE, GLASS (70165-003-15) 450 ml2017-09-160000-00-00NoNoCurrent